N/A
N=44
Effect of Weight Loss on Prostate Cancer Pathology
Obesity · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00475982 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Apoptotic Index of the Highest Gleason Grade Malignant Epithelium in the Radical Prostatectomy Specimen Obtained After 8-weeks of the Dietary Intervention — 6.9; 5.0 percentage of cells stained — p=0.965
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Weight Loss (Behavioral); No Weight Loss Group (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apoptotic Index of the Highest Gleason Grade Malignant Epithelium in the Radical Prostatectomy Specimen Obtained After 8-weeks of the Dietary Intervention |
6.9; 5.0 | 0.965 |
| SECONDARY Proliferative Index in Prostate Cancer Epithelium Specimen |
6.69; 5.79 | 0.884 |
| SECONDARY Change in Serum IGF-related Analytes: IGF-1 |
165.8; 127.9; 171.2; 124.8; 5.38; -3.12 | 0.294 |
| SECONDARY Change in Serum IGF-related Analytes: IGFBP-1 |
8.78; 16.7; 10.9; 16.6; 2.19; -0.03 | 0.162 |
| SECONDARY Ex-vivo Mitogenic and Apoptotic Activity of Patient Sera on LNCaP Cells |
92.8; 84.8; 90.8; 83.5; -2.01; -1.24 | 0.283 |
| SECONDARY Change in Body Weight |
102.19; 101.02; 98.47; 99.38; -3.71; -1.60 | 0.00 sig |
| SECONDARY Change in Percent Body Fat |
36.8; 36.5; 35.9; 36.9; -0.93; 0.41 | 0.073 |
Summary
The purpose of this study is to determine if weight loss prior to radical prostatectomy effects chemical substances in the blood stream and prostate tissue that may affect prostate cancer development and progression.
Eligibility Criteria
Inclusion Criteria
- Subject is overweight or obese (BMI > 25 kg/m2)
- Patient with pathologically confirmed adenocarcinoma of the prostate and has elected to undergo radical prostatectomy
- Willing to delay radical prostatectomy for 5 to 8-weeks if randomized to the weight loss intervention group.
- Able to adhere to physical activity intervention (able to walk for 30 minutes without rest)
- Able to come to the VA for weight loss visits during the 5 to 8-wk study
Exclusion Criteria
- Any one of the following: Gleason grade > 4+4, PSA > 20.
- History of ever receiving androgen deprivation therapy, antiandrogen therapy, or finasteride
- Prior prostate radiotherapy (external beam or brachytherapy) or prior cryotherapy
- Diagnosis of diabetes mellitus and on insulin**
- Current use of weight loss medications or enrolled in a diet/weight loss program
- Current use of lycopene supplements*** Significant co-morbidities (i.e. cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) Cardiac pacemaker
Data sourced from ClinicalTrials.gov (NCT00475982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.